GOG 152

Secondary surgical cytoreduction for advanced ovarian carcinoma

Pubmed

First Author: Rose PG

Hypothesis: Secondary debulking in sub optimally >1 cm tumor patients after 3 cycles of chemotherapy improves survival

Site: Ovary

Experimental arm: Suboptimal surgery –> 3 cycles of cisplatin 75 mg/m2 Paclitaxel 135 mg/m2 q-24 hr –>Secondary debulking –> 3 further cycles

Standard Arm: Suboptimal surgery –> 6 cycles of cisplatin 75 mg/m2 Paclitaxel 135 mg/m2 q-24 hr

Primary Outcome: OS

Arm Distribution:

Experimental arm (secondary debulking arm): N=208 (Serous 76%, Endometrioid 8%, Measurable disease at 3 cycles 1-2 cm 12%, 2-5 cm 43%, 5-10 cm 33%, > 10 cm 12%)

Standard arm (no secondary debulking): N=216 (Serous 76%, Endometrioid 5%, Measurable disease at 3 cycles 1-2 cm 12%, 2-5 cm 44%, 5-10 cm 38%, > 10 cm 6%)

Results:

Outcome Secondary debulking Chemotherapy only p-value
PFS (Months) 10.5 10.7 NS
OS 33.9 33.7 NS
Neuropathy G2/4 16% 26% SS
GI G2/4 7% 4% SS

Conclusions: If maximum surgical effort up front (by a gynecologic oncologist), no benefit to interval cytoreduction


GOG 172

Intraperitoneal cisplatin and paclitaxel in ovarian cancer

Pubmed

First Author: Armstrong DK

Hypothesis: IP chemotherapy improves overall survival in optimally debulked ovarian cancer

Site: Ovary

Experimental arm: 135 mg/m2 paclitaxel (IV-24hrs) cisplatin 100 mg/m2 IP day 2 60 mg Paclitaxel IP day 8 (All IP meds with 2 L warm saline)

Standard Arm: 135 mg/m2 Paclitaxel (IV-24hrs) cisplatin 75mg/m2 IV on day 2

Primary Outcome: Overall survival

Results:

Outcome IP/IV IV only p-value
PFS 23.8 18 SS
OS 65.6 49.7 SS
Completed all planned cycles 42% 83% SS
G3/G4Toxicity
GI 46% 24% SS
Neutropenia 76% 64% SS
Neuropathy 19% 9% SS
Fatigue 18% 4% SS

Conclusions: Significant improvement in PFS and OS in optimally debulked patients (<1 cm)

Controversies (Select editorials worth reading)

Pro IP chemotherapy

Against IP chemotherapy